NCT06616467Active, not recruiting
Cognitive-Behavioral Intervention to Increase Tummy Time Practice and Maintain Healthy Weight in Infants
Cognitive-Behavioral Intervention Targeting Mothers to Increase Tummy Time Practice and Maintain Healthy Weight in Infants
Source: ClinicalTrials.gov · Last updated 20 Feb 2025
Brief summary (registry, in English)
Childhood obesity is a serious health problem worldwide evidenced by its high prevalence, specifically for the age group called the first 1000 days of life. This condition has serious consequences on the health of infants who suffer from it, being a precursor for the development of diseases such as diabetes and hypertension. For this reason, international organizations have proposed physical activity as a priority component for the prevention of childhood obesity. The objective of this study is to evaluate the preliminary effect of an intervention based on social cognitive theory aimed at Mexican mothers with children under six months of age to increase the practice of Tummy Time and maintain the healthy weight of the infant compared to usual care. The methodology will be a pilot randomized clinical trial with randomization to the Experimental Group and Control Group, the intervention will be with a single-blind approach and repeated measurements. A non-probabilistic sampling will be used for convenience and the sample will be 144 participants who will be dyads of mothers and children who are in the immediate postpartum hospitalized in a second-level hospital in Mexico.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 24 Sept 2024
- Start date
- 2 Sept 2024
- Primary completion date
- 14 Dec 2024
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Diseases
- Obesity
- NCT number
- NCT06616467
What you commit to
- Study type: Interventional
- Planned participants: 144
- From 2 Sept 2024 to the primary completion date, 14 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women who report having received information about TT one month before the intervention.
Other illness
- who has a medical condition or complication at birth that impacts their physical mobility and
Other
- Women who are actively participating in programs related to early stimulation
- Who declare that they have a premature infant born before 37 SDG,
- who has a low birth weight \<2,500g,
- who has chronic health problems or congenital anomalies.
Who the study is looking for
- Mother-child dyads that are in the postpartum
- mothers who declare that they know how to read and write in spanish
- have an electronic device (cell phone, tablet or computer),
- have an internet connection.
- Have the social network WhatsApp®
- Agree to participate voluntarily evidenced by informed consent will be considered
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Dr. Jose Eleuterio González Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.